Anti-immunoglobulin E therapy with omalizumab for asthma

Annals of Pharmacotherapy

Volumn 41, Issue 9, 2007, Pages 1397-1410

  Hendeles, Leslie ^a,c   Sorkness, Christine A ^b  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^c NONE   (United States)

Author keywords

Asthma; Immunoglobulin E; Monoclonal antibody

Indexed keywords

ACETYLSALICYLIC ACID; ADRENALIN; ANTIHISTAMINIC AGENT; BECLOMETASONE; BECLOMETASONE DIPROPIONATE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; FC RECEPTOR; FLUNISOLIDE; FLUTICASONE; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; HOUSE DUST ALLERGEN; IMMUNOGLOBULIN E; IMMUNOGLOBULIN E ANTIBODY; IMMUNOGLOBULIN E RECEPTOR; IMMUNOGLOBULIN G; INTERLEUKIN 1BETA; LEUKOTRIENE RECEPTOR BLOCKING AGENT; MONTELUKAST; NONSTEROID ANTIINFLAMMATORY AGENT; OMALIZUMAB; PENICILLIN DERIVATIVE; PLACEBO; PREDNISOLONE; SALBUTAMOL; STEROID; THEOPHYLLINE; TRIAMCINOLONE; UNINDEXED DRUG;

ALLERGIC REACTION; ANAPHYLAXIS; ARTICLE; ASTHMA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CORTICOSTEROID THERAPY; DEATH; DRUG COST; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; HUMAN; IMMUNE COMPLEX DISEASE; IMMUNOTHERAPY; INJECTION SITE REACTION; KIDNEY INJURY; MALIGNANT NEOPLASTIC DISEASE; MEDLINE; PATIENT COMPLIANCE; PATIENT SELECTION; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SERUM SICKNESS; SIDE EFFECT; SKIN DISEASE; THROAT DISEASE; TONGUE EDEMA; TREATMENT DURATION; URTICARIA;

ANTI-ASTHMATIC AGENTS; ANTIBODIES, MONOCLONAL; ASTHMA; COST-BENEFIT ANALYSIS; HUMANS; IMMUNOGLOBULIN E; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS; TREATMENT OUTCOME;

EID: 34548145543     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1K005     Document Type: Article

References (54)

1. Centers for Disease Control and Prevention (CDC). Environmental hazards and health effects program. Asthma. Program in brief. www.cdc.gov/asthma/ program.htm (accessed 2006 Oct 26).
2. American Lung Association. Lung disease data: 2006. www.lungusa.org/atf/ cf/{7A8D42C2-FCCA-4604-8ADE-7F5D5E762256}/LDD2006 (accessed 2007 Feb 20).
3. Chung KF. Unmet needs in adult asthma. Clin Exp Allergy 2000;30(suppl 1):66-9.
4. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Clinical practice guidelines: expert panel report 2. Guidelines for the diagnosis and management of asthma. Bethesda, MD: National Institutes of Health, National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program; 1997. NIH publication 97-4051.
5. Dolan CM, Fraher KE, Bleecker ER, et al. Design and baseline characteristics of The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study: a large cohort of patients with severe or difficult-to-treat asthma. Ann Allergy Asthma Immunol 2004;92:32-9.
6. Bateman ED, Boushey HA, Bousquet J, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med 2004;170:836-44.
7. Global Initiative for Asthma (GINA). Pocket guide for asthma management and prevention. Medical Communications Resources, Inc., 2006. www.ginasthma.com/Guidelineitem.asp??11=2&12=1&intID=37 (accessed 2007 Aug 3).
8. National Asthma Education and Prevention Program. Full report of the Expert Panel: guidelines for the diagnosis and management of asthma (EPR-3). Washington, DC: National Heart, Lung, and Blood Institute, DRAFT January 2007.
9. Presta LG, Lahr SJ, Shields RL, et al. Humanization of an antibody directed against IgE. J Immunol 1993;151:2623-32.
10. MacGlashan D Jr, McKenzie-White J, Chichester K, et al. In vitro regulation of FcepsilonRIalpha expression on human basophils by IgE antibody. Blood 1998;91:1633-43.
11. Huang YC, Leyko B, Frieri M. Effects of omalizumab and budesonide on markers of inflammation in human bronchial epithelial cells. Ann Allergy Asthma Immunol 2005;95:443-51.
12. Lin H, Boesel KM, Griffith DT, et al. Omalizumab rapidly decreases nasal allergic response and FcepsilonRI on basophils. J Allergy Clin Immunol 2004;113:297-302.
13. Beck LA, Marcotte GV, MacGlashan D, Togias A, Saini S. Omalizumab-induced reductions in mast cell Fc epsilon RI expression and function. J Allergy Clin Immunol 2004;114:527-30.
14. Prussin C, Griffith DT, Boesel KM, Lin H, Foster B, Casale TB. Omalizumab treatment downregulates dendritic cell FcepsilonRI expression. J Allergy Clin Immunol 2003;112:1147-54.
15. Djukanovic R, Wilson SJ, Kraft M, et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med 2004;170:583-93.
16. Prieto L, Gutierrez V, Colas C, et al. Effect of omalizumab on adenosine 5′-monophosphate responsiveness in subjects with allergic asthma. Int Arch Allergy Immunol 2006;139:122-31.
17. Noga O, Hanf G, Brachmann I, et al. Effect of omalizumab treatment on peripheral eosinophil and T-lymphocyte function in patients with allergic asthma. J Allergy Clin Immunol 2006;117:1493-9.
18. Package insert. Xolair (omalizumab). San Francisco, CA: Genentech, Inc., June 2003.
19. Hochhaus G, Brookman L, Fox H, et al. Pharmacodynamics of omalizumab: implications for optimised dosing strategies and clinical efficacy in the treatment of allergic asthma. Curr Med Res Opin 2003;19:491-8.
20. Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J 2001;18:254-61.
21. Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol 2001;108:184-90.
22. Buhl R, Soler M, Matz J, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J 2002;20:73-8.
23. Lanier BQ, Corren J, Lumry W, Liu J, Fowler-Taylor A, Gupta N. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol 2003;91:154-9.
24. Humbert M, Beasley R, Ayres J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy 2005;60:309-16.
25. Ayres JG, Higgins B, Chilvers ER, Ayre G, Blogg M, Fox H. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy 2004;59:701-8.
26. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics 2001;108:e36(1-10).
27. Holgate S, Bousquet J, Wenzel S, Fox H, Liu J, Castellsague J. Efficacy of omalizumab, an anti-immunoglobulin E antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity and mortality. Curr Med Res Opin 2001;17:233-40.
28. Corren J, Casale T, Deniz Y, Ashby M. Omalizumab, a recombinant humanized anti-IgE antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma. J Allergy Clin Immunol 2003;111:87-90.
29. Niebauer K, Dewilde S, Fox-Rushby J, Revicki DA. Impact of omalizumab on quality-of-life outcomes in patients with moderate-to-severe allergic asthma. Ann Allergy Asthma Immunol 2006;96:316-26.
30. Buhl R, Hanf G, Soler M, et al. The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma. Eur Respir J 2002;20:1088-94.
31. Finn A, Gross G, van Bavel J, et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol 2003;111:278-84.
32. Holgate ST, Chuchalin AG, Hebert J, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004;34:632-8.
33. Lemanske RF Jr, Nayak A, McAlary M, Everhard F, Fowler-Taylor A, Gupta N. Omalizumab improves asthma-related quality of life in children with allergic asthma. Pediatrics 2002;110:e55.
34. Vignola AM, Humbert M, Bousquet J, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy 2004;59:709-17.
35. Deniz YM, Gupta N. Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. Clin Rev Allergy Immunol 2005;29:31-48.
36. Milgrom H, Fick RB Jr, Su JQ, et al. Treatment of allergic asthma with monoclonal anti-IgE antibody, rhuMAb-E25 Study Group. N Engl J Med 1999;341:1966-73.
37. FDA Alert. Information for Healthcare Professionals. Omalizumab. www.fda.gov/cder/drug/infopage/omalizumab/default.htm (accessed 2007 Mar 23).
38. Lieberman P. Anaphylaxis and anaphylactoid reactions. In: Middleton E, Reed CE, Ellis EF, Adkinson NF, Yunginger JW, Busse WW, eds. Allergy: principles and practice. 5th ed. St. Louis, MO: Mosby-Year Book, Inc., 1998:1079.
39. Data on file. San Francisco: Genentech, Inc.
40. Berger W, Gupta N, McAlary M, Fowler-Taylor A. Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma. Ann Allergy Asthma Immunol 2003;91:182-8.
41. The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair (omalizumab) During Pregnancy (EXPECT). Identifier NCT00373061. www.clinicaltrials.gov/ct/show/NCT00373061?order=1 (accessed 2007 Mar 26).
42. De Smet BD, Erickson SR, Kirking DM. Self-reported adherence in patients with asthma. Ann Pharmacother 2006;40:414-20. Epub 28 Feb 2006. DOI 10.1345/aph.1G475
43. Sherman J, Patel P, Hutson A, Chesrown S, Hendeles L. Adherence to oral montelukast and inhaled fluticasone in children with persistent asthma. Pharmacotherapy 2001;21:1464-7.
44. Weinstein AG. Should patients with persistent severe asthma be monitored for medication adherence? Ann Allergy Asthma Immunol 2005;94:251-7.
45. Walley J, Newell J, Khan A. Directly observed therapy and treatment adherence (letter). Lancet 2000;356:1031-2.
46. Hendeles L, Khan Y, Massanari M, Spencer T, Shuster J, Chesrown S. The effect of omalizumab on airway responsiveness to adenosine in asthma patients with poor adherence to inhaled steroids (abstract). Am J Respir Crit Care Med 2007;175:A58.
47. Bousquet J, Wenzel S, Holgate S, Lumry W, Freeman P, Fox H. Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma. Chest 2004;125:1378-86.
48. Bang LM, Plosker GL. Spotlight on omalizumab in allergic asthma. BioDrugs 2004;18:415-8.
49. Lowe P, Jaffe J, Martin C, Brookman L, Fox H. The effect of discontinuing omalizumab therapy on free IgE concentration (abstract). J Allergy Clin Immunol 2007;119(suppl):S6.
50. Oba Y, Salzman GA. Cost-effectiveness analysis of omalizumab in adults and adolescents with moderate-to-severe allergic asthma. J Allergy Clin Immunol 2004;114:265-9.
51. Miller TP, Reeves MJ. Lack of cost-effectiveness of omalizumab. J Allergy Clin Immunol 2005;115:429-30.
52. Asche CV, Brixner DI, Oderda GM. Has the cost-effectiveness of Xolair (omalizumab) been underestimated? J Allergy Clin Immunol 2005;115:1095-6.
53. Rosenwasser LJ, Nash DB. Incorporating omalizumab into asthma treatment guidelines: Consensus Panel recommendations. Pharm Ther 2003;28:400-14.
54. Marshall GD Jr, Sorkness CA. IgE-blocking therapy for difficult-to-treat asthma: a brief review. Manag Care 2004;13:45-50.